BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTC MARGRON HIP REPLACEMENT SYSTEM

    MDR report key: 1022029 · Received April 1, 2008

    Report

    Report Number
    9613642-2008-00024
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    October 30, 2006
    Report Date
    March 31, 2008
    Manufacturer
    PORTLAND ORTHOPAEDICS LTD.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MARGRON HIP REPLACEMENT WAS USED IN AN EXTREMELY COMPLEX PRIMARY SURGERY IN A PT WITH A STIFF HIP; THE PT HAD BEEN PREVIOUSLY REJECTED BY OTHER SURGEONS DUE TO THE DIFFICULTY OF THE CASE. AFTER THE PRIMARY PROCEDURE, AND WITH TIME, THE PROSTHESIS BECAME VERY MOBILE WITH HYPEREXTENSION AND IMPINGEMENT OF THE ACETABULAR CUP AGAINST THE FEMORAL COMPONENT. TO ACCOUNT FOR A CHANGE IN THE FEMORAL NECK POSITION A 'LONGER' CERAMIC HEAD WAS INSERTED DURING THE REVISION SURGERY. PT OUTCOME WAS VERY SATISFACTORY. THE MARGRON HIP REPLACEMENT WAS KEPT IN PLACE DURING THE REVISION SURGERY, AND ANOTHER MFR'S FEMORAL HEAD WAS REPLACED TO MEET THE PHYSIOLOGICAL CHANGES IN THE PT OVER TIME. THE REVISION SURGERY WAS NOT RELATED TO MARGRON HIP REPLACEMENT. THE EVENT IS BEING REPORTED FOLLOWING A REASSESSMENT BY PORTLAND ORTHOPAEDICS. THE REASSESSMENT WAS CONDUCTED AFTER A TREND REGARDING EARLY REVISION RATES WITH THE MARGRON DEVICE WAS OBSERVED BY ANOTHER COUNTRY ORTHOPAEDIC ASSOCIATION IN ITS 2007 NATIONAL JOINT REGISTRY REPORT. THIS OBSERVED TREND AND PORTLAND'S INITIAL ANALYSIS WERE PREVIOUSLY REPORTED TO FDA IN MDR NO. 9613642-2008-00001. AS A PRECAUTIONARY MEASURE, PORTLAND HAS TAKEN THE MARGRON DTC SYSTEM OFF THE MARKET IN THE U.S. PENDING FURTHER EVALUATION OF THE DEVICE AND EVENTS, EXCEPT FOR CASES IN WHICH MARGRON -SPECIFIC TOOLS OR COMPONENTS ARE NECESSARY TO PERFORM REVISION OF A MARGRON IMPLANT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON A MARGRON HIP REPLACEMENT DUE TO PT SYMPTOMS OF DISCOMFORT EXPERIENCED FROM THE IMPLANT, INCLUDING 'CLICKING' NOISES AND CATCHING. THE MARGRON HIP REPLACEMENT WAS ORIGINALLY IMPLANTED IN AN EXTREMELY COMPLEX PRIMARY SURGERY IN A PT WITH A STIFF HIP. THE MARGRON HIP REPLACEMENT WAS KEPT IN PLACE DURING THE REVISION SURGERY, AND ANOTHER MFR'S FEMORAL HEAD WAS REPLACED TO MEET THE PHYSIOLOGICAL CHANGES IN THE PT OVER TIME. THE REVISION SURGERY WAS NOT RELATED TO THE MARGRON HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTC MARGRON HIP REPLACEMENT SYSTEM FEMORAL NECK LPH PORTLAND ORTHOPAEDICS LTD. NA 807

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CERAMIC FEMORAL HEAD 28M| DTC MODULAR EXTENSION ZZ6| DTC FEMORAL STEM Z+1